Improved breast cancer diagnosis using a CA15-3 capture antibody-lectin sandwich assay.

ABSTRACT:

Purpose

This study aims to test the hypothesis that an enzyme-linked antibody-lectin sandwich assay for a glycovariant of CA15-3 can deliver better diagnostic performance, defined by classification accuracy, sensitivity and specificity, for breast cancer compared to an existing FDA-approved CA15-3 test.

Methods

A genetically engineered lectin (SubB2M) that specifically binds N-glycolylneuraminic acid (Neu5Gc) was used as a detection reagent in a CA15-3 capture antibody-lectin sandwich (neuCA15-3) assay. In a case: control cohort equivalence study the classification accuracy for the neuCA15-3 assay was determined and compared to an FDA-approved CA15-3 IVD test (Elecsys CA15-3 II, Roche Diagnostics).

Results

Classification accuracy and AUC for neuCA15-3 were 81% and 0.8

SUBMITTER: Nikseresht S 

PROVIDER: S-EPMC12031999 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature